whitepaper
Whitepaper: Annual PQR: A thing of the past
Anytime PQR is the new way of generating APQR by automating the reports anytime in 3 easy steps. Now make the entire process system driven with CaliberAPQR.
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QA/QC
podcasts
EPR Podcast Episode 13 – QC spectroscopy compliance – Garry Wright and Julia Griffen, Agilent
Discover the common compliance concerns encountered when using spectroscopy instruments for QC, as well as how to rectify them in this episode with Agilent Technologies.
whitepaper
Product hub: How can CGT manufacturers ensure product safety with Microbial Solutions QC test methods?
Innovation forms the basis of every emerging technology. That is certainly the case with cell and gene therapies (CGTs), and the search for efficient quality control (QC) test methods continues to grow in this pharmaceutical sector. One of the most important factors to consider while deciding on a QC method…
news
Assessing the scale of pharmaceutical crime using API content
Reviewing the active pharmaceutical ingredient (API) content in essential medicines failing quality analyses in low- and middle-income countries (LMICs) reveals that more than 12 percent are substandard or falsified.
article
API nitrosamines: method sensitivity issues
Here, David Elder discusses the risks presented by active pharmaceutical ingredient nitrosamines and explains how European and US guidance differs on their acceptable levels.
article
Securing every dose with an edible security technology for safe medicines
The problem of counterfeit medicines is becoming a tremendous burden to society. An edible security tag affixed to each medicine can provide track and trace measures with dose information and on-dose (in-dose) authentication. Furthermore, it serves as a last line of defence against illicit pharmaceutical products. Young Kim, Associate Head…
news
Blister material as a source of nitrosamine impurities
Study reveals lidding foil with nitrocellulose primer is a potential source of nitrosamine impurities for pharmaceuticals, especially when using plate sealing equipment.
article
Progress in the implementation of biofluorescent particle counters
Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
article
A strategic approach to optimisations of testing bacterial endotoxins
Given industry's recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise. They also explore some of the short-term…
article
European Pharmaceutical Review Issue 4 2022
In EPR Issue 4, experts discuss implementing a global strategy to improve the sustainability of endotoxin testing, how to accelerate timelines for manufacture of multi-specific antibodies and the potential of oncolytic viruses as a therapy for glioblastoma. Also featured: progress towards smart vaccine manufacturing, an update on edible anticounterfeiting technology,…
news
Common pharma compliance concerns cited by FDA warning letters
A review of the last decade of FDA warning letters finds quality control operations, manufacturing process validation, and data record and integrity are the key points of scrutiny.
news
Does terminal sterilisation affect the quality of ophthalmic APIs?
EPR summarises research into the impact of gamma irradiation and ethylene oxide sterilisation treatments on European Pharmacopoeial compliance of common ophthalmic APIs.
whitepaper
Whitepaper: A beginner’s guide to AI driven pharmacovigilance platform
In this whitepaper, authors have shared their experience on AI-driven technology adoption in pharmacovigilance.
video
On-demand webinar: The advantages of cartridge technology
Why do pharmaceutical manufacturers still believe older methods are reliable for quality testing when there’s superior technology available on the market?
news
Pharmacopoeias to further support vaccine development and supply
US and European Pharmacopoeias announce new activities to help promote vaccine development, manufacturing, quality and supply.
